hemangiosarcoma, epithelioid hemangioendothelioma, and malignant solitary fibroma/hemangioperidoma
Conditions
Interventions
Test group:bevacizumab
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, at least 18 years old, at least 75 years old; 2. Voluntarily sign informed consent; 3. ECOG score: 0-2; 4. Advanced patients with hemangiosarcoma, epithelioid hemangioendothelioma, malignant solitary fibroma/hemangioperioma confirmed by histopathology or imaging and unable to receive surgical treatment; 5. According to RECIST 1.1 efficacy evaluation criteria for solid tumors, CT indicated that there was at least one radiologically measurable or evaluable lesion; 6. No previous treatment; 7. Expected survival > 3 months; 8. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) negative within 7 days prior to inclusion and be willing to use an appropriate method of contraception or have been sterilized during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 9. The following criteria are met if the major organs are functioning properly: (1) The standard of blood routine examination shall be met (no blood transfusion or blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors) : a. Hemoglobin (HGB) =90 g/L b. neutrophil absolute value (ANC) =1.5×10 9 /L c. Platelet (PLT) =100×10 9 /L (2) Biochemical examination shall meet the following standards: a. Total bilirubin (TBIL) =1.5× upper limit of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN (ALT or AST =5×ULN in patients with liver metastasis); c. Serum creatinine (Cr) =1.25×ULN and endogenous creatinine clearance (using Cockcroft-Gault formula) =60 ml/min d. Urine protein: It meets one of the following (other tests may not be performed if it meets any of the test criteria)(1) Urine protein (paper method)2+ or <2+(2) Urine protein creatinine (UPC) ratio < 3.5(3)24 h urine protein determination: urine protein ?3500 mg e. Prothrombinase Time (PT) - International Normalized Ratio (INR): ?1.5 (INR ?3.0 if receiving anticoagulation therapy) (3) Good coagulation function, defined as International Normalized ratio (INR) =1.5×ULN, or prothrombin time (PT) =ULN+4 seconds, or activated partial thrombin time (APTT) =1.5×ULN Under the premise of INR=1.5×ULN, low-dose heparin (adult daily dose: 0.6000-12,000 U) or low-dose aspirin (daily dose: 100 mg or less) is permitted for preventive purposes. (4) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range; (5) The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included);
Exclusion criteria
Exclusion criteria: 1. Allergic to experimental drugs; 2. Had received antitumor therapy, including radiotherapy and surgery, within 4 weeks prior to enrollment, and had received perioperative chemotherapy, palliative chemotherapy or other molecular targeted therapy within 6 months prior to enrollment; 3. According to imaging findings, metastatic lesions of the central nervous system were present. 4. Patients with gastrointestinal perforation and/or fistula during the 6 months prior to enrollment; Or experienced arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 5. Any history of active immune or autoimmune diseases, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. Active or uncontrolled severe infection (=CTC AE grade 2 infection) occurred within 4 weeks prior to enrollment; 7. A history of hypertension that cannot be well controlled after medication (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); 8. Bleeding symptoms of significant clinical significance or definite bleeding tendency occurred within the first three months of enrollment; 9. Had grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QTc =480ms), and = grade 2 congestive heart failure (New York Heart Association (NYHA) grade) within 6 months prior to enrollment; 10. Diagnosed with other malignant tumors within 3 years prior to enrollment; 11.HIV positive persons with cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 12. Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment; 13. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 14. In the investigator's judgment, there is a concomitant disease or any other condition that seriously endangers patient safety, may confuse the study results, or may interfere with the patient's completion of the study. 15. Pregnant or lactating women; 16. Women or men of childbearing age did not consent to use effective contraceptive methods during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactDongyuan Zhu
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed